Status:
RECRUITING
Azithromycin and Ampicillin for Late PPROM
Lead Sponsor:
Sheba Medical Center
Conditions:
Pregnancy Complications, Infectious
Premature Birth
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes...
Detailed Description
Preterm premature rupture of membranes (PPROM) occurs in 1-3% of all pregnancies and accounts for approximately 30% of all preterm births. It is associated with significant maternal, fetal, and neonat...
Eligibility Criteria
Inclusion
- Maternal age 18-50
- Premature rupture of membranes
- Gestational age 34.0 and 36.4 weeks
- Singleton pregnancy
Exclusion
- Multiple gestations
- Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)
- Meconium stain amniotic fluid
- Non-reassuring fetal heart rate or status
- Maternal or fetal indication for labor:
- Suspected Chorioamnionitis
- Suspected placental abruption
- Any maternal morbidity requiring labor
- Cervical cerclage in place.
- Major fetal malformation or known chromosomal abnormalities.
- Stillbirth.
- Sensitivity to Macrolides Antibiotics
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT07183462
Start Date
September 10 2025
End Date
July 31 2029
Last Update
December 18 2025
Active Locations (1)
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1
Sheba medical center
Ramat Gan, Israel, Israel